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Table 2 Analysis of patients with adverse events and discontinuations

From: Discontinuation rates in clinical trials in musculoskeletal pain: meta-analysis from etoricoxib clinical trial reports

Outcome/comparisons

Number of

Rate of events (%)

Relative risk (95% CI)

NNTp/NNH (95% CI)

 

Trials

Patients

Etoricoxib

Comparator

  

All cause

      

   Etoricoxib versus placebo (4 to 12 weeks)

16

6,388

17

32

0.6 (0.53 to 0.63)a

6.7 (5.8 to 7.8)b

   NSAID versus placebo (4 to 12 weeks)

10

3,690

26

32

0.9 (0.80 to 0.99)a

19 (13 to 31)b

   Etoricoxib versus NSAID (4 to 12 weeks)

12

5,186

17

22

0.7 (0.65 to 0.82)a

16 (11 to 29)b

   Etoricoxib versus NSAID (all trials)

17

39,881

47

51

0.95 (0.93 to 0.97)a

31 (24 to 44)b

Lack of efficacy

      

   Etoricoxib versus placebo (4 to 12 weeks)

16

6,388

7.2

22

0.4 (0.32 to 0.41)a

7.4 (6.3 to 8.9)b

   NSAID versus placebo (4 to 12 weeks)

10

3,690

9.1

23

0.5 (0.45 to 0.62)a

6.6 (5.9 to 7.6)b

   Etoricoxib versus NSAID (4 to 12 weeks)

12

5,186

7.6

7.5

1.0 (0.8 to 1.2)

 

   Etoricoxib versus NSAID (all trials)

17

39,881

8.8

9.5

0.9 (0.86 to 0.97)a

145 (80 to 820)b

Clinical adverse event

      

   Etoricoxib versus placebo (4 to 12 weeks)

16

6,388

5.1

4.4

1.2 (0.9 to 1.4)

 

   NSAID versus placebo (4 to 12 weeks)

10

3,690

8.2

3.8

1.8 (1.4 to 2.4)a

23 (17 to 35)c

   Etoricoxib versus NSAID (4 to 12 weeks)

12

5,186

5

8.2

0.7 (0.53 to 0.81)a

31 (22 to 54)b

   Etoricoxib versus NSAID (all trials)

17

39,881

17

18

1.0 (0.94 to 1.02)

 

Laboratory adverse event

      

   Etoricoxib versus placebo (4 to 12 weeks)

16

6,388

0.7

0.7

0.9 (0.5 to 1.7)

 

   NSAID versus placebo (4 to 12 weeks)

10

3,690

0.7

0.6

0.9 (0.4 to 2.1)

 

   Etoricoxib versus NSAID (4 to 12 weeks)

12

5,186

0.3

0.5

0.6 (0.3 to 1.4)

 

   Etoricoxib versus NSAID (all trials)

17

39,881

1.2

3.3

0.4 (0.34 to 0.45)a

49 (43 to 57)b

Gastrointestinal adverse event

      

   Etoricoxib versus placebo (4 to 12 weeks)

16

6,388

1.9

1.7

1.3 (0.9 to 1.8)

 

   NSAID versus placebo (4 to 12 weeks)

10

3,690

4.7

1.6

2.6 (1.7 to 3.9)

33 (24 to 52)c

   Etoricoxib versus NSAID (4 to 12 weeks)

12

5,186

2.0

4.1

0.5 (0.38 to 0.73)a

47 (33 to 85)b

   Etoricoxib versus NSAID (all trials)

17

39,881

4.4

7.7

0.6 (0.54 to 0.63)a

30 (27 to 35)b

Serious adverse event

      

   Etoricoxib versus placebo (4 to 12 weeks)

16

6,388

0.9

0.7

1.0 (0.6 to 1.7)

 

   NSAID versus placebo (4 to 12 weeks)

10

3,690

0.9

0.6

1.2 (0.6 to 2.4)

 

   Etoricoxib versus NSAID (4 to 12 weeks)

12

5,186

0.7

0.9

0.8 (0.5 to 1.6)

 

   Etoricoxib versus NSAID (all trials)

17

39,881

5.5

5.3

1.1 (0.98 to 1.2)

 

Hypertension

      

   Etoricoxib versus placebo (4 to 12 weeks)

16

6,388

0.4

0.04

1.6 (0.8 to 3.5)

 

   NSAID versus placebo (4 to 12 weeks)

10

3,690

0.5

0.1

2.0 (0.8 to 4.9)

 

   Etoricoxib versus NSAID (4 to 12 weeks)

12

5,186

0.5

0.5

1.0 (0.5 to 2.0)

 

   Etoricoxib versus NSAID (all trials)

17

39,881

2.1

1.3

1.7 (1.4 to 1.9)a

120 (94 to 180)c

Oedema

      

   Etoricoxib versus placebo (4 to 12 weeks)

16

6,388

0.3

0.1

1.2 (0.6 to 2.6)

 

   NSAID versus placebo (4 to 12 weeks)

10

3,690

0.4

0.1

1.6 (0.6 to 4.2)

 

   Etoricoxib versus NSAID (4 to 12 weeks)

12

5,186

0.3

0.4

1.1 (0.5 to 2.3)

 

   Etoricoxib versus NSAID (all trials)

17

39,881

1.0

0.7

1.5 (1.2 to 1.9)a

320 (200 to 720)c

  1. Note that nonsteroidal anti-inflammatory drugs (NSAIDs) indicates traditional NSAIDs only. aStatistically significant difference in relative risk. bNumber needed to treat to prevent an event (NNTp). cNumber needed to cause an event (NNH). CI, confidence interval.